Table 3.
Safety summary.
| Event | Ipilimumab 3 mg/kg (n = 40) | Ipilimumab 10 mg/kg (n = 42) |
|---|---|---|
| Death, n (%) | ||
| All | 18 (45.0) | 20 (47.6) |
| Within 70 days of last dose | 8 (20.0) | 8 (19.0) |
| Within 30 days of last dose | 3 (7.5) | 4 (9.5) |
| Serious AE, n (%) | ||
| All | 18 (45.0) | 20 (47.6) |
| Drug-related | 7 (17.5) | 8 (19.0) |
| AE leading to study discontinuation, n (%) | 5 (12.5) | 11 (26.2) |
| Drug-related AE, n (%) | ||
| Any grade | 33 (82.5) | 32 (76.2) |
| Grade 3-4 | 6 (15.0) | 13 (31.0) |
| Grade 5 | 1 (2.5) | 1 (2.4) |
| irAE, n (%) | ||
| Overall | ||
| Any grade | 22 (55.0) | 28 (66.7) |
| Grade 3-4 | 3 (7.5) | 8 (19.0) |
| Grade 5 | 1 (2.5) | 1 (2.4) |
| GI | ||
| Any grade | 11 (27.5) | 19 (45.2) |
| Grade 3-4 | 3 (7.5) | 3 (7.2) |
| Grade 5 | 1 (2.5) | 1 (2.4) |
| Liver | ||
| Any grade | 0 | 2 (4.8) |
| Grade 3-4 | 0 | 2 (4.8) |
| Endocrine | ||
| Any grade | 2 (5.0) | 2 (4.8) |
| Grade 3-4 | 0 | 2 (4.8) |
| Skin | ||
| Any grade | 16 (40.0) | 21 (50.0) |
| Grade 3-4 | 0 | 1 (2.4) |
| Other | ||
| Any grade | 1 (2.5) | 3 (7.1) |
| Grade 3-4 | 0 | 1 (2.4) |
AE: adverse event; GI: gastrointestinal; irAE: immune-related adverse event.